This is the third post in a series of posts in which I share what I see as the ups and downs of the Genetic Information Nondiscrimination Act of 2008 (GINA or H.R. 493). In this post I address a potential positive:
A little discussed portion of GINA may be cause for celebration. Title II, Section 208, Subsection (b) of GINA calls for the establishment of the Genetic Nondiscrimination Study Commission after GINA has been enacted for six years. The purpose of the Commission is to evaluate the status of genetic science, genetic discrimination, public perception, and other factors, and to make recommendations to Congress regarding possible future legislation. Here, it would seem as though Congress has exercised a reasonable amount of foresight. Scientific knowledge is expanding at an amazing rate; faster than society and its laws can react, resulting in public fear and apprehension. Public fears are important and they must be listened to; public fears shouldn't always determine legislative action, but they cannot be brushed aside or ignored. In this case, Congress seemed to understand this dichotomy. They did the research. They listened to experts, and they acted. – Sam Beasley
Showing posts with label public engagement. Show all posts
Showing posts with label public engagement. Show all posts
Saturday, June 7, 2008
Friday, February 22, 2008
The Genetics & Public Policy Center - Public Consultation Dates
The Genetics & Public Policy Center at Johns Hopkins University recently released the dates for its upcoming town hall discussions to "gather feedback from the public on their views related to a proposed large cohort study on the role of genes and environment in health". Meetings will be held March 8th (Kansas City, MO), April 5th (Phoenix, AZ), April 19th (Jackson, MS), April 24th (Portland, OR), and May 13th (Philadelphia, PA). These meetings follow similar meetings in the same cities last year. The scheduled "town hall" meetings are a part of the second stage in a two-year, $2 million pilot project funded by the National Human Genome Research Institute, "Making Every Voice Count: Public Consultation on Genetics, Environment, and Health". The results of last year's public consultations regarding the feasibility of a pediatric biobank were recently published in the American Journal of Medical Genetics:
Kaufman D, Geller G, Leroy L, Murphy J, Scott J, Hudson K. Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion. Am J Med Genet C Semin Med Genet. 2008 Feb 15;148(1):31-9. PMID:18189289
Kaufman D, Geller G, Leroy L, Murphy J, Scott J, Hudson K. Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion. Am J Med Genet C Semin Med Genet. 2008 Feb 15;148(1):31-9. PMID:18189289
Tuesday, February 5, 2008
Genetic Research: Groups and Potential Harm
Anyone interested in public engagement and community consultation in genetic research will appreciate Daniel Hausman's article "Protecting Groups from Genetic Research" (Bioethics 2008; 22 (3):157-65). Hausman provides a clear, well-written taxonomy of group types and potential harms to these types as a result of genetic research. He identifies three kinds of groups: structured groups – those with corporate interests distinct from the interests of their individual members (for example, indigenous groups with existing or potential corporate property); identifying groups – unstructured groups (Italian Americans or Ashkenazi women, for example); and potentially identifying groups – those that may be identified as a result of genetic research.
Hausman's taxonomy of harms includes two process-related harms (disrupting and stigmatizing harms) and two outcomes-related harms (undermining and stereotyping harms). Disrupting harms occur, he writes, "when the research process – regardless of its findings – harms a structured group". For example, "taking tissue samples in genetics research might have a ritual significance that could undermine group solidarity". The author thinks that these harms are relatively infrequent in genetic research.
Stigmatizing harms, in contrast, are more common. This process-related harm affects individuals of an identifying group when the mere existence of a genetic research study stigmatizes members of the group.
The third harm, undermining, (an outcomes-related harm) occurs when structured groups are hurt by the findings of genetic research. For examples, Hausman provides the refutation of beliefs about group origins, the loss of potential commercial gain, and the generation or justification of discriminatory treatment.
The fourth kind of harm, also an outcomes-related harm, stereotyping, affects members of identifying groups. If a member of an ethic group were denied insurance coverage because of a genetic susceptibility was perceived to be common to this group, this individual would be the victim of stereotyping.
As would be expected, given the complexities of developing local, national and international research oversight, civic legislation and public consultation, Hausman's proposed protections against these harms are not as well-defined. Here are a few highlights: IRBs - The author does not think that expanding IRB oversight is answer. He writes, "IRBs are not well suited to implement the necessary regulation ... there would be a duplication of oversight, and research would be stymied ... [and they] are not the right bodies to regulate the risks that scientific research poses to third parties." Group engagement – Although he thinks that efforts toward community consultation in genetic research grow "out of an admirable concern to be respectful to individuals and groups that the research may put at risk," the author argues that consultation is primarily valuable when conducting research with structured groups. In contrast, he thinks that consultation with identifying groups facing stereotyping harms (African Americans, for example) is "often infeasible". He writes, "Indeed, by lending salience to social groups, that may in fact be genetically heterogeneous, group consultation may be counterproductive". To protect groups from stereotyping, Hausman hesitatingly (fearing, perhaps, a decline in public support for research) advocates regulation.
Readers looking for more detailed suggestions for protecting groups from genetic research may be frustrated by this article. For example, the author concludes, regarding harms to indigenous groups, that "whoever regulates research (to the extent that research is regulated) should be concerned about the risks of undermining ... and should demand that researchers provide those they study with detailed information and the opportunity to make their concerns heard by political and regulatory authorities". To my ears, such a statement sounds too much like: someone should pick up this trash ... which is not an effective way to motivate people to clean a room. Readers may also wonder if Hausman too quickly dismisses the possibility of protecting the third group type in his taxonomy, "potential identifying" groups. While it is true that one can not consult with a group that is yet to be identified, does this mean that some protections can not be explored or established in advance?
While I hope that Hausman, or someone else, will pick up the loose ends that this article did not have the room to address, his taxonomy of groups and potential harms is very useful. If you can find a copy of this article (subscription required, unfortunately), it's worth reading. –J.O.
Reference: Hausman D. Protecting groups from genetic research. Bioethics 2008; 22 (3):157-65. [Abstract - CiteULike | doi:10.1111/j.1467-8519.2007.00625.x]
Hausman's taxonomy of harms includes two process-related harms (disrupting and stigmatizing harms) and two outcomes-related harms (undermining and stereotyping harms). Disrupting harms occur, he writes, "when the research process – regardless of its findings – harms a structured group". For example, "taking tissue samples in genetics research might have a ritual significance that could undermine group solidarity". The author thinks that these harms are relatively infrequent in genetic research.
Stigmatizing harms, in contrast, are more common. This process-related harm affects individuals of an identifying group when the mere existence of a genetic research study stigmatizes members of the group.
The third harm, undermining, (an outcomes-related harm) occurs when structured groups are hurt by the findings of genetic research. For examples, Hausman provides the refutation of beliefs about group origins, the loss of potential commercial gain, and the generation or justification of discriminatory treatment.
The fourth kind of harm, also an outcomes-related harm, stereotyping, affects members of identifying groups. If a member of an ethic group were denied insurance coverage because of a genetic susceptibility was perceived to be common to this group, this individual would be the victim of stereotyping.
As would be expected, given the complexities of developing local, national and international research oversight, civic legislation and public consultation, Hausman's proposed protections against these harms are not as well-defined. Here are a few highlights: IRBs - The author does not think that expanding IRB oversight is answer. He writes, "IRBs are not well suited to implement the necessary regulation ... there would be a duplication of oversight, and research would be stymied ... [and they] are not the right bodies to regulate the risks that scientific research poses to third parties." Group engagement – Although he thinks that efforts toward community consultation in genetic research grow "out of an admirable concern to be respectful to individuals and groups that the research may put at risk," the author argues that consultation is primarily valuable when conducting research with structured groups. In contrast, he thinks that consultation with identifying groups facing stereotyping harms (African Americans, for example) is "often infeasible". He writes, "Indeed, by lending salience to social groups, that may in fact be genetically heterogeneous, group consultation may be counterproductive". To protect groups from stereotyping, Hausman hesitatingly (fearing, perhaps, a decline in public support for research) advocates regulation.
Readers looking for more detailed suggestions for protecting groups from genetic research may be frustrated by this article. For example, the author concludes, regarding harms to indigenous groups, that "whoever regulates research (to the extent that research is regulated) should be concerned about the risks of undermining ... and should demand that researchers provide those they study with detailed information and the opportunity to make their concerns heard by political and regulatory authorities". To my ears, such a statement sounds too much like: someone should pick up this trash ... which is not an effective way to motivate people to clean a room. Readers may also wonder if Hausman too quickly dismisses the possibility of protecting the third group type in his taxonomy, "potential identifying" groups. While it is true that one can not consult with a group that is yet to be identified, does this mean that some protections can not be explored or established in advance?
While I hope that Hausman, or someone else, will pick up the loose ends that this article did not have the room to address, his taxonomy of groups and potential harms is very useful. If you can find a copy of this article (subscription required, unfortunately), it's worth reading. –J.O.
Reference: Hausman D. Protecting groups from genetic research. Bioethics 2008; 22 (3):157-65. [Abstract - CiteULike | doi:10.1111/j.1467-8519.2007.00625.x]
Friday, November 23, 2007
Barriers to Research and Strategies for Community Engagement: Three Recent Papers
PredictER Blog and the PredictER program have an ongoing interest in encouraging community engagement in genetic and predictive health research. Patrick Barrett introduced this mission in the previous PredictER Blog post (November 19, 2007.) For those with an interest in reading the latest research on this topic, here are brief summaries of three recent papers:
Grand challenges in global health: community engagement in research in developing countries ...
Tindana PO, Sing JA, and et al. provide a short review of community engagement (CE) concepts for research in developing countries and discuss two models in Africa. Although the authors note that community engagement goals "have become prominent in research policy", they point to divergent definitions of CE and the need for evaluation. They caution that "there is a growing recognition that communities, not just individuals, can suffer harm from participation in research. For example, with out adequate protections, population genetics research runs the risk of stigmatizing or discriminating against recognizable communities ....". The authors plan to document CE in developing countries and to develop preliminary guidelines to facilitate CE in research.
Community engagement in epidemiological research ...
Sapienza JN, Corbie-Smith G, Keim S, and Fleishcman AR outline the CE practices and plan of The National Children's Study (NCS). In introducing the project, they note that CE "can be quite complex, even within a single site due to the difficulty researchers have in defining communities". In addition to the difficulty of defining "community" they add that "finding key community leaders that will best represent [the] multitude of community views and perspectives" can be a challenge.
An examination of community members', researchers' and health professionals' perceptions of barriers to minority participation in medical research ...
Robinson JM and Trochim WMK, in a "concept mapping" study of perceived barriers to minority participation in research, demonstrate that the research system (in addition to the often discussed lack of trust in researchers) contributes to lower participation rates. The authors also discuss the discrepancy between how health professionals and community members define these barriers. They conclude with three recommendations for improved minority participation rates in health research: (1) improve relationships between the medical research community and the communities they serve; (2) increase the levels and improve the nature of community involvement in the research process; and (3) efforts must be multi-dimensional, addressing both community interrelations and research process issues.
Citations:
Robinson JM and Trochim WMK. An examination of community members', researchers' and health professionals' perceptions of barriers to minority participation in medical research: an application of concept mapping. Ethnicity and Health 2007; 12(5):521-39.
DOI: 10.1080/13557850701616987 PredictER CiteULike [abstract]
Sapienza JN, Corbie-Smith G, Keim S, and Fleishcman AR. Community engagement in epidemiological research. Ambul Pediatr 2007; 7(3): 247-52.
PubMed ID: 17512886 PredictER CiteULike [abstract]
Tindana PO, Singh JA, Tracy CS, Upshur RE, Daar AS, Singer PA, Frohlich J , Lavery JV. Grand challenges in global health: community engagement in research in developing countries. PLoS Med. 2007 Sep 11;4(9):e273
PubMed ID: 1785017 PredictER CiteULike [abstract]
Grand challenges in global health: community engagement in research in developing countries ...
Tindana PO, Sing JA, and et al. provide a short review of community engagement (CE) concepts for research in developing countries and discuss two models in Africa. Although the authors note that community engagement goals "have become prominent in research policy", they point to divergent definitions of CE and the need for evaluation. They caution that "there is a growing recognition that communities, not just individuals, can suffer harm from participation in research. For example, with out adequate protections, population genetics research runs the risk of stigmatizing or discriminating against recognizable communities ....". The authors plan to document CE in developing countries and to develop preliminary guidelines to facilitate CE in research.
Community engagement in epidemiological research ...
Sapienza JN, Corbie-Smith G, Keim S, and Fleishcman AR outline the CE practices and plan of The National Children's Study (NCS). In introducing the project, they note that CE "can be quite complex, even within a single site due to the difficulty researchers have in defining communities". In addition to the difficulty of defining "community" they add that "finding key community leaders that will best represent [the] multitude of community views and perspectives" can be a challenge.
An examination of community members', researchers' and health professionals' perceptions of barriers to minority participation in medical research ...
Robinson JM and Trochim WMK, in a "concept mapping" study of perceived barriers to minority participation in research, demonstrate that the research system (in addition to the often discussed lack of trust in researchers) contributes to lower participation rates. The authors also discuss the discrepancy between how health professionals and community members define these barriers. They conclude with three recommendations for improved minority participation rates in health research: (1) improve relationships between the medical research community and the communities they serve; (2) increase the levels and improve the nature of community involvement in the research process; and (3) efforts must be multi-dimensional, addressing both community interrelations and research process issues.
Citations:
Robinson JM and Trochim WMK. An examination of community members', researchers' and health professionals' perceptions of barriers to minority participation in medical research: an application of concept mapping. Ethnicity and Health 2007; 12(5):521-39.
DOI: 10.1080/13557850701616987 PredictER CiteULike [abstract]
Sapienza JN, Corbie-Smith G, Keim S, and Fleishcman AR. Community engagement in epidemiological research. Ambul Pediatr 2007; 7(3): 247-52.
PubMed ID: 17512886 PredictER CiteULike [abstract]
Tindana PO, Singh JA, Tracy CS, Upshur RE, Daar AS, Singer PA, Frohlich J , Lavery JV. Grand challenges in global health: community engagement in research in developing countries. PLoS Med. 2007 Sep 11;4(9):e273
PubMed ID: 1785017 PredictER CiteULike [abstract]
Monday, November 19, 2007
Engaging the Community in Predictive Health Research: Reporting on PredictER's November 2nd Expert Panel
Research and the Community
In most predictive health projects, researchers need to obtain human biological materials that can be stored for immediate or later use and then linked to detailed health information from medical records. Building biobanks and predictive health research projects requires a supportive public. To succeed researchers need a representative sample of willing participants, good state and institutional policy, and (of course) funding. (This research also benefits from highly motivated advocacy groups such as Susan G. Komen for the Cure.) In a few words, predictive health is one of the most community saturated forms of medical research to date.
Ethical Issues
The great good that will be accomplished by predictive health research, with its ability to forecast a person’s health future with reasonable probability, must be pursued with careful consideration. These studies raise ethical, legal, and social questions beyond the scope of the current paradigm of medical research. Very basic examples of these questions include: What do researchers do when they find that an individual tests positive for a gene or other biomarker that puts them at significant risk for a disease in the future? Can an individual’s biological material be used first to study one type of disease or treatment and then later another? What protections need to be in place to ensure that the sensitive information in an individual’s health record and genes does not result in employment or health insurance discrimination?
The Pace of Translation
While questions like these may seem very scary when rattled off one after the other, the truth is that predictive health is the future of medicine--a future that hopes to fulfill the ambitions of the human genome project, by providing an individual with a personalized assessment of risk and response to treatment. The human genome project succeeded in decoding a great deal of information, but what that information means for individuals with heart disease, a family history of cancer, or a smoking addiction, has not been answered. If current research succeeds, this information will be translated into real clinical applications in the not too distant future. Research looking to define these types of predictors is well underway at most universities--some, as exemplified by Emory's Predictive Health Initiative and the TGen (Translational Genomics) project in Arizona, have worked to establish comprehensive predictive health research programs. Meanwhile, as The Wall Street Journal recently reported many (up to 1,400) genetic tests are already available for individuals interested in assessing their risks for a number of diseases. Moreover, many specific predictive tests are already being used to chart treatment paradigms in hospital care.
PredictER Engaging the Community
Still, the fact that predictive health is occurring does not answer any of the concerns voiced earlier. These are concerns that the PredictER program at the IU Center for Bioethics is working to address. On November 2nd, PredictER convened a panel of 35 experts and community advocates to begin to give shape to many of these concerns and to explore ways to reach out to the community, build collaboration, and encourage research while protecting individual and public interests. While the panel of experts shared an understanding of the progress of predictive health, it took an entire day of brainstorming and discussion to reach consensus on what issues may be present with respect to engaging the community. In the end, it was clear that predictive health will require physicians, researchers, and the community to join in constructive, mutually beneficial work. In the near future a white paper will be published by the Center for Bioethics with a more detailed account of the November 2nd event. This paper will also introduce the next step in PredictER's community outreach mission--a plan to engage central Indiana community leaders and to listen to their concerns about the future of predictive health research. -- Patrick Barrett
In most predictive health projects, researchers need to obtain human biological materials that can be stored for immediate or later use and then linked to detailed health information from medical records. Building biobanks and predictive health research projects requires a supportive public. To succeed researchers need a representative sample of willing participants, good state and institutional policy, and (of course) funding. (This research also benefits from highly motivated advocacy groups such as Susan G. Komen for the Cure.) In a few words, predictive health is one of the most community saturated forms of medical research to date.
Ethical Issues
The great good that will be accomplished by predictive health research, with its ability to forecast a person’s health future with reasonable probability, must be pursued with careful consideration. These studies raise ethical, legal, and social questions beyond the scope of the current paradigm of medical research. Very basic examples of these questions include: What do researchers do when they find that an individual tests positive for a gene or other biomarker that puts them at significant risk for a disease in the future? Can an individual’s biological material be used first to study one type of disease or treatment and then later another? What protections need to be in place to ensure that the sensitive information in an individual’s health record and genes does not result in employment or health insurance discrimination?
The Pace of Translation
While questions like these may seem very scary when rattled off one after the other, the truth is that predictive health is the future of medicine--a future that hopes to fulfill the ambitions of the human genome project, by providing an individual with a personalized assessment of risk and response to treatment. The human genome project succeeded in decoding a great deal of information, but what that information means for individuals with heart disease, a family history of cancer, or a smoking addiction, has not been answered. If current research succeeds, this information will be translated into real clinical applications in the not too distant future. Research looking to define these types of predictors is well underway at most universities--some, as exemplified by Emory's Predictive Health Initiative and the TGen (Translational Genomics) project in Arizona, have worked to establish comprehensive predictive health research programs. Meanwhile, as The Wall Street Journal recently reported many (up to 1,400) genetic tests are already available for individuals interested in assessing their risks for a number of diseases. Moreover, many specific predictive tests are already being used to chart treatment paradigms in hospital care.
PredictER Engaging the Community
Still, the fact that predictive health is occurring does not answer any of the concerns voiced earlier. These are concerns that the PredictER program at the IU Center for Bioethics is working to address. On November 2nd, PredictER convened a panel of 35 experts and community advocates to begin to give shape to many of these concerns and to explore ways to reach out to the community, build collaboration, and encourage research while protecting individual and public interests. While the panel of experts shared an understanding of the progress of predictive health, it took an entire day of brainstorming and discussion to reach consensus on what issues may be present with respect to engaging the community. In the end, it was clear that predictive health will require physicians, researchers, and the community to join in constructive, mutually beneficial work. In the near future a white paper will be published by the Center for Bioethics with a more detailed account of the November 2nd event. This paper will also introduce the next step in PredictER's community outreach mission--a plan to engage central Indiana community leaders and to listen to their concerns about the future of predictive health research. -- Patrick Barrett
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